Received May 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046731 | IM |
altered mental status; increased agitation; slow response; limited speech; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) in an elderly male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever). At the time of the report, MENTAL DISORDER (altered mental status), AGITATION (increased agitation), SLOW RESPONSE TO STIMULI (slow response), SPEECH DISORDER (limited speech) and PYREXIA (fever) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. This case contains information about 1st patient out of 2 patients as reported by reporter. No concomitant medications were reported. HCP stated that patient received a Spikevax dose in October 2024, but no other vaccines in the last four weeks and was unable to provide medical history. HCP stated that patient changed from the regular baseline and ended up going to the emergency room. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2025-785851 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785851:Patient 02